Nationwide drug recall likely to deepen shortages

The recall of all drugs from a Massachusetts manufacturer — in the latest response to the meningitis outbreak — will most likely exacerbate a critical shortage of at least six drugs that were already in short supply.

Hundreds of products were recalled Wednesday by Ameridose, a sister company to New England Compounding Center that is at the center of the Food and Drug Administration’s investigation into the fungal meningitis outbreak that has killed 29 and sickened more than 400. The FDA recommended the recall after saying that it “could not assure the sterility” of Ameridose products but has offered no other details.

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And the Massachusetts Board of Registration in Pharmacy confirmed Friday that it had reached an agreement with Ameridose to keep the facility closed for two additional weeks — it was first shuttered Oct. 10 — so that state regulators can finish inspecting it.

The anticipated drop-off in the supply of drugs already in short supply is menacing hospital pharmacies around the country. The FDA says it is scrambling to help boost supplies, but experts expect shortages to grow in coming weeks.

“It’s kind of like watching [Hurricane] Sandy move up the coast before she took that left hook and slammed into us,” said Joseph Hill, director of federal legislative affairs for the American Society of Health-System Pharmacists. “At least it’s got that potential.”

In particular, sodium bicarbonate, which is stocked “in every unit on every floor of every hospital,” may be in danger of disappearing entirely from some hospitals, said Erin Fox, manager of the Drug Information Service at University of Utah Health Care. “It is extremely critical already.”

Sodium bicarbonate is an injectable drug that is used in a wide variety of clinical situations, including in “advanced cardiac life support,” according to ASHP. “It’s in every crash code box,” Fox said.

On Friday, FDA Commissioner Margaret Hamburg wrote in a blog post that the “recall may affect supplies of certain lifesaving drugs for some health systems.” Hamburg wrote that the FDA is taking the same actions it has taken to prevent other drug shortages — asking manufacturers to ramp up production, working with them to resolve any outstanding manufacturing quality problems, and looking overseas to possibly import supplies.

But an FDA representative on Friday could not say whether any of these potential remedies had been successful so far in relieving the additional shortages expected from the Ameridose recall.

The squeeze put on the supply chain by the recall of Ameridose products and temporary closure of its plant is emblematic of the conditions that have led to the growing problem of drug shortages, which have peaked in the past two years.

Ameridose was one of just four companies producing sodium bicarbonate after the largest supplier, American Regent, quit making it, Fox said. The major generic drug company Hospira had picked up some of the slack but had to scale back after the FDA identified production problems.

“Hospira continues to manufacture sodium bicarbonate and is making progress restoring production to previous levels,” spokesman Dan Rosenberg said in a statement. “We understand the critical market need.”

Two other companies also make it, but the combined output can’t keep pace with demand, Fox said.

Sodium bicarbonate is just one of six drugs produced by Ameridose that were already in short supply.